INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PONSTAN CAPSULES
PONSTAN FORTE (tablet)
PONSTAN SUSPENSION
PONSTAN PAEDIATRIC SUPPOSITORIES
SCHEDULING STATUS:
S3

PROPRIETARY NAMES
(and dosage forms):

PONSTAN CAPSULES
PONSTAN FORTE (tablet)
PONSTAN SUSPENSION
PONSTAN PAEDIATRIC SUPPOSITORIES

COMPOSITION:
Ponstan Capsules:         250 mg mefenamic acid per capsule
Ponstan Forte: 500 mg mefenamic acid per tablet
Ponstan Suspension: 50 mg mefenamic acid in each 5 mL medicine measure.
        Alcohol         0,5% v/v
        Preservative: Sodium benzoate         0,5% m/v
Ponstan Paediatric Suppositories: 125 mg mefenamic acid per suppository

PHARMACOLOGICAL CLASSIFICATION:
A: 2.7 Anti-pyretic or anti-pyretic and anti-inflammatory analgesics.

PHARMACOLOGICAL ACTION:
Ponstan has analgesic, anti-inflammatory and anti-pyretic properties.
The pharmacological activity of Ponstan may be due in part to its ability to inhibit the synthesis of prostaglandins. Ponstan also inhibits the action of exogenous prostaglandins on uterine muscle, uterine tube contraction and ovarian cyclic AMP and progesterone formation in animal models.
Pharmacokinetics and Metabolism:
Mefenamic acid is well absorbed from the gastro-intestinal tract. Peak plasma concentrations occur in about 2 to 4 hours, with a half-life of 2 to 4 hours. Plasma levels are proportional to dose, following multiple doses, with no drug accumulation.
Mefenamic acid is extensively bound to plasma proteins. Over 50% of the dose may be recovered in the urine as unchanged drug or conjugated metabolites.

INDICATIONS:
S2: For the symptomatic treatment of post traumatic conditions such as pain, swelling and inflammation, for a maximum period of 5 days. For the symptomatic treatment of primary dysmenorrhoea for a maximum period of 3 days.
S3: For the relief of mild to moderate pain in acute and chronic conditions including pain of traumatic, arthritic or muscular origin; primary dysmenorrhoea, headache and dental pain.
  It is also indicated as an anti-pyretic in febrile conditions.
  Ponstan reduces blood loss in menorrhagia where the menorrhagia is due to ovulatory dysfunctional bleeding. Uterine and other pathology should first be excluded before prescribing Ponstan for this indication.
  Ponstan Suppositories are indicated for the symptomatic treatment of pain and fever in children 6 months to 2 years when oral therapy is not possible.

CONTRA-INDICATIONS:
Sensitivity to mefenamic acid and other nonsteroidal anti-inflammatory agents with prostaglandin-synthetase inhibiting activity. Because the possibility exists for cross-sensitivity among nonsteroidal anti-inflammatory agents, Ponstan should not be given to patients in whom these drugs induce symptoms of bronchospasm, allergic rhinitis, or urticaria.
Ponstan is contra-indicated in patients with chronic inflammation of either the upper or lower gastro-intestinal tract, in patients with a history of peptic and/or intestinal ulceration, patients with impaired renal or hepatic function, and epilepsy.
Safety in pregnancy and lactation has not yet been established.

WARNING:
If diarrhoea or skin rash appear, Ponstan should be discontinued immediately.
Blood counts and liver function should be monitored during long-term therapy.
Ponstan may enhance the effects of oral anticoagulants (See Drug Interactions).

DOSAGE AND DIRECTIONS FOR USE:
Therapy should not be continued for longer than 7 days.
Adults:        500 mg three times per day.
In menorrhagia the dosage is 500 mg three times a day beginning with the onset of menstrual flow and continuing for five days or until cessation of flow, whichever is less.
In primary dysmenorrhoea the dosage is 500 mg three times a day commencing at the onset of period pain and continued for up to three days while the symptoms persist.
Children (6 months and older): 25 mg/kg of body weight daily, in divided doses, or:
6 months to 1 year: One medicine measureful (5 mL).
2 to 4 years: Two medicine measuresful (10 mL).
5 to 8 years: Three medicine measuresful (15 mL).
9 to 12 years: Four medicine measuresful (20 mL).
The dose may be repeated as necessary, up to three times daily.
Gastric irritation may be reduced by taking medication during meals.

Paediatric Suppositories:
Children 6 months to 2 years, weighing not less than 10 kg: One suppository to be inserted rectally three times a day at intervals of 6 to 8 hours as needed.
One 125 mg suppository is equivalent to approximately 60 mg (6 mL) Ponstan suspension.
The use of paediatric suppositories every 6 to 8 hours for longer than 24 hours is not recommended.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
The most frequently reported side-effects were gastro-intestinal disturbances, and include diarrhoea, nausea with or without vomiting and abdominal pain.
Diarrhoea may occur within 24 hours following usual analgesic dosage. When diarrhoea occurs, the medication should be discontinued immediately. Temporary lowering of the white blood cell count has occurred but does not appear to be dose-related. Blood counts should be performed at regular intervals during long-term administration.
Serious gastro-intestinal toxicity such as bleeding, ulceration, and perforation can occur at any time with or without warning symptoms, in patients treated chronically with nonsteroidal anti-inflammatory agents. Elderly or debilitated patients seem unable to tolerate ulceration or bleeding as well as some other individuals; most spontaneous reports of gastro-intestinal events are in this population.
Less frequently reported gastrointestinal side effects include anorexia, pyrosis, flatulence, enterocolitis, colitis, steatorrhoea, cholestatic jaundice, hepatitis, pancreatitis, hepatorenal syndrome, mild hepatic toxicity, constipation and peptic ulceration with and without gastro-intestinal haemorrhage.
Headache, drowsiness, dizziness, nervousness, convulsions, insomnia, visual disturbances and ear pain have been reported.
Other side-effects which may occur are hypotension, asthma, glucose intolerance in diabetic patients, palpitations and dyspnea.
Haemolytic anaemia may develop in patients taking Ponstan continuously for extended periods. While this condition is generally reversible, death due to Ponstan-associated haemolytic anaemia has been reported. Liver function tests must be carried out regularly to monitor elevation of enzymes and bilirubin.
Other reported haematological effects include agranulocytosis, decreased hematocrit, leukopenia, eosinophilia, aplastic anaemia, pancytopenia, thrombocytopenia or thrombocytopenic purpura and bone marrow aplasia.
Acute hypersensitivity reactions (urticaria, bronchospasm, anaphylaxis) have occurred. Because of the possibility of cross-sensitivity due to structural relationships which exist among nonsteroidal anti-inflammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds.
Angioedema, oedema of the larynx, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), erythema multiforme, perspiration, urticaria, rash and facial oedema may occur. Occurrence of rash is a definite reason for stopping medication because exfoliative dermatitis has been reported on continued use after development of a rash.
Renal failure, allergic glomerulonephritis, papillary necrosis, dysuria and hyponatremia have occurred. There have been reports of acute interstitial nephritis with haematuria, proteinuria, and occasionally nephrotic syndrome.
Drug Interactions:
Patients receiving an anticoagulant drug concurrently with Ponstan have had a prolongation of prothrombin time. Ponstan is contraindicated for patients taking an anticoagulant drug if careful and continuous monitoring of the levels of prothrombin and Factors VII, IX and X is not available.
Patients receiving lithium concurrently with NSAIDs, including Ponstan, have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. Thus, when Ponstan and lithium are administered concurrently, patients should be observed carefully for signs of lithium toxicity.
Precautions:
Caution should be exercised in the administration of Ponstan to patients suffering from dehydration and/or renal disease, particularly the elderly.
Bronchoconstriction may occur with mefenamic acid in asthmatic patients with aspirin sensitivity.
Mefenamic acid and its metabolites may give a false positive reaction to certain urine tests for the presence of bile.
Toxicity has also been seen in patients with prerenal condition leading to a reduction in renal blood flow or blood volume. Patients at greatest risk are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics, and the elderly.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special precautions".
Mefenamic acid has a marked tendency to induce tonic-clonic (grand mal) convulsions in overdosage. Dyskinesia, acute renal failure and coma have been reported. Overdose has led to fatalities.
Treatment is symptomatic and supportive. Following accidental overdosage, the stomach should be emptied by inducing emesis or gastric lavage followed by administration of activated charcoal. Vital functions should be monitored and supported. Haemodialysis is of little value since mefenamic acid and its metabolites are firmly bound to plasma proteins.

PRESENTATION:
Ponstan Capsules: Containers of 100 and 250, and blisters of 12.
Ponstan Forte: Containers of 50.
Ponstan Suspension: Bottles of 100 mL, 200 mL and 2,5 L.
Ponstan Paediatric suppositories: Packs of 5

IDENTIFICATION:
Ponstan Capsules: Ivory opaque body and aqua blue opaque cap, imprinted "Parke-Davis" and "Ponstan 250".
Ponstan Forte: Buff-coloured, round, biconvex tablets.
Ponstan Suspension: A creamy, opaque, off-white suspension with a pleasant characteristic odour and taste.
Ponstan Paediatric Suppositories: Creamy white, bullet-shaped suppositories.

STORAGE INSTRUCTIONS:
Store in a cool (below 25°C), dry place. Ponstan Forte to be protected from direct sunlight.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
Ponstan Capsules:         B/2.7/560
Ponstan Forte:         H/2.7/13
Ponstan Suspension:         B/2.7/561
Ponstan Paediatric Suppositories:         27/2.7/0561

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pfizer Laboratories (Pty) Ltd
102 Rivonia Road
SANDTON, 2196
South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 June 1994
        Revised: OCT 02; MAY 00; JUN 99; OCT 97; OCT 95.

Updated on this site: January 2005
Source: Pharmaceutical Industry

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